08-3771-ag 

IN THE UNITED STATES COURT OF APPEALS 

FOR THE SECOND CIRCUIT 

____________________________ 

NATURAL RESOURCES DEFENSE COUNCIL, INC., 

Petitioner, 

v. 

 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, 

Respondent. 

______________________________ 

On Petition for Review from the U.S. Environmental Protection Agency 

________________________________ 

RESPONDENT’S BRIEF 

________________________________ 

 IGNACIA S. MORENO 

 Assistant Attorney General 

Of Counsel: KENT E. HANSON 

 U.S. Department of Justice 

JONATHAN J. FLEUCHAUS Environment & Natural Resources Division 

U.S. E.P.A. P.O. Box 23986 

Office of General Counsel Washington, D.C. 20026-3986 

Washington, D.C. 20460 202-514-2327 

November 18, 2010 Counsel for Respondent EPA 
i

TABLE OF CONTENTS 

JURISDICTIONAL STATEMENT ............................................................................ 1 

STATEMENT OF ISSUES ......................................................................................... 1 

STATEMENT OF THE CASE .................................................................................... 2 

I. Introduction ........................................................................................................ 2 

II. Statutory and Regulatory Background ............................................................... 4 

 A. The FFDCA’s Statutory Scheme .............................................................. 5 

 B. Administrative Procedures Governing Petitions to Revoke FFDCA 

Pesticide Tolerances ................................................................................. 7 

 C. Endocrine Screening Program .................................................................. 9 

 D. Human Research Rule .............................................................................. 10 

III. Procedural History of the NRDC Petitions ......................................................... 12 

 A. FIFRA Reregistration/FFDCA Tolerance Reassessment for DDVP ....... 14 

 B. NRDC’s Petition to Revoke Tolerances ................................................... 16 

 C. EPA’s Response to the Petition to Revoke Tolerances ............................ 17 

 D. NRDC’s Objections .................................................................................. 21 

 E. EPA’s Denial of Objections and Hearing Requests ................................. 23 

STANDARD OF REVIEW ......................................................................................... 27 

SUMMARY OF ARGUMENT ................................................................................... 30 
ii

ARGUMENT ............................................................................................................... 34 

I. NRDC Did Not Satisfy the Standard for Obtaining an Evidentiary Hearing 

 Under the FFDCA ............................................................................................... 34 

 

 A. NRDC’s claims regarding the statistical power of the DDVP human 

 study did not raise issues of fact material to EPA’s tolerance 

 decision ..................................................................................................... 36 

 B. NRDC presented no evidence that raised material issues of fact on 

 which NRDC could reasonably prevail on the question of whether 

 the Gledhill study’s informed consent process met ethical standards ...... 46 

 C. EPA did not deny any hearing request based on consideration of the 

 burden of holding a hearing ...................................................................... 51 

II. EPA’s Decision to Apply a 3X Children’s Safety Factor was Neither 

Contrary to Law Nor Arbitrary or Capricious .................................................... 53 

 A. EPA properly denied NRDC’s objection to EPA’s children’s safety 

 factor decision based on the absence of data from endocrine 

 screening program because it was not raised in NRDC’s petition ........... 53 

 B. EPA’s authority to establish an appropriate children’s safety factor 

 does not depend on the completion of the endocrine screening 

 program ..................................................................................................... 54 

 C. EPA supported its children’s safety factor decision with reliable, 

 DDVP-specific data .................................................................................. 57 

CONCLUSION ............................................................................................................ 64 
iii

 TABLE OF AUTHORITIES 

CASES

Browning-Ferris Indus. of S. Jersey, Inc., v. Muszynski, 

 899 F.2d 151 (2d Cir. 1990) ............................................................... 29, 60 

Cmty. Nutrition Inst. v. Young, 

 773 F.2d 1356 (D.C. Cir. 1985) ............................................................... 29 

Ethyl Corp. v. EPA, 

 541 F.2d 1 (D.C. Cir. 1976) (en banc) ............................................... 28, 30 

Nader v. EPA, 

 859 F.2d 747 (9th Cir. 1988) ................................................................... 45 

Nat'l Corn Growers Ass'n v. EPA, 

 613 F.3d 266 (D.C. Cir. 2010) ............................. 29, 36, 40, 46, 52, 53, 63 

New York v. Reilly, 

 969 F.2d 1147 (D.C. Cir. 1992) ............................................................... 29 

NRDC v. Johnson, 

 461 F.3d 164 (2d Cir. 2006) ..................................................................... 45 

NRDC v. Muszynski, 

 268 F.3d 91 (2d Cir. 2001) ....................................................................... 28 

Nw. Coal. for Alternatives to Pesticides v. EPA, 

 544 F.3d 1043 (9th Cir. 2008) ........................................................... 29, 62 

Rainwater v. Alarcon, 

 268 Fed. Appx. 531 (9th Cir. 2008) ......................................................... 47 

Riverkeeper, Inc. v. EPA, 

 358 F.3d 174 (2d Cir. 2004) ............................................................... 28, 30 
iv

Rodriguez v. City of New York, 

 72 F.3d 1051 (2d Cir. 1995) ..................................................................... 47 

Semler v. Oregon State Bd. of Dental Exam'rs, 

 294 U.S. 608 (1935) ................................................................................. 47 

Small Refiner Lead Phase-Down Task Force v. EPA, 

 705 F.2d 506 (D.C. Cir. 1983) ................................................................. 29 

Triton Energy Corp. v. Square D Co., 

 68 F.3d 1216 (9th Cir. 1995) ................................................................... 60 

Weinberger v. Hynson, Westcott & Dunning, Inc., 

 412 U.S. 609 (1973) ........................................................................... 36, 52 

 

RULES

Fed. R. Civ. P. 56(c)(2) ................................................................................. 35 

STATUTES

5 U.S.C. §§ 551-559...................................................................................... 27 

5 U.S.C. § 706(2)(A) ..................................................................................... 28 

7 U.S.C. § 136 - 136y ..................................................................................... 4 

21 U.S.C. § 331(a) .......................................................................................... 5 

21 U.S.C. § 342(a)(2)(B) ................................................................................ 5 

21 U.S.C. § 346a ......................................................................................... 1, 5 

21 U.S.C. § 346a(a) ......................................................................................... 5 

21 U.S.C. § 346a(a)(1)-(2) .............................................................................. 5 

21 U.S.C. § 346a(b)(2)(A)(i) .......................................................................... 5 
v

21 U.S.C. § 346a(b)(2)(A)(ii) ..................................................................... 5, 6 

21 U.S.C. § 346a(b)(2)(C) ........................................................................ 6, 61 

21 U.S.C. § 346a(b)(2)(C)(i) ..................................................................... 6, 55 

21 U.S.C. § 346a(b)(2)(C)(i)(II) ................................................................... 63 

21 U.S.C. § 346a(b)(2)(C)(ii) ......................................................................... 6 

21 U.S.C. § 346a(b)(2)(D) .............................................................................. 6 

21 U.S.C. § 346a(d)-(g) .................................................................................. 7 

21 U.S.C. § 346a(d)(1)(A) .............................................................................. 7 

21 U.S.C. § 346a(d)(2) and (3) ....................................................................... 7 

21 U.S.C. § 346a(d)(4)(A) .............................................................................. 7 

21 U.S.C. § 346a(g) ...................................................................................... 34 

21 U.S.C. § 346a(g)(2) .................................................................................. 40 

21 U.S.C. § 346a(g)(2)(A) .................................................................... 1, 8, 45 

21 U.S.C. § 346a(g)(2)(B) ........................................................................ 8, 49 

21 U.S.C. § 346a(g)(2)(C) .............................................................................. 8 

21 U.S.C. § 346a(h) ........................................................................................ 1 

21 U.S.C. § 346a(h)(1) .................................................................................... 1 

21 U.S.C. § 346a(p) .................................................................................. 9, 56 

21 U.S.C. § 346a(q) ...................................................................................... 14 
vi

 CODE OF FEDERAL REGULATIONS

40 C.F.R. § 26.1602(b)(2) ............................................................................. 12 

40 C.F.R. § 26.1603 ................................................................................ 11, 12 

40 C.F.R. § 26.1701 ...................................................................................... 11 

40 C.F.R. § 26.1704 ...................................................................................... 11 

40 C.F.R. § 158.500(d) ................................................................................. 10 

TABLE OF AUTHORITIES 

CASES

Browning-Ferris Indus. of S. Jersey, Inc., v. Muszynski, 

 899 F.2d 151 (2d Cir. 1990) ............................................................... 29, 60 

Cmty. Nutrition Inst. v. Young, 

 773 F.2d 1356 (D.C. Cir. 1985) ............................................................... 29 

Ethyl Corp. v. EPA, 

 541 F.2d 1 (D.C. Cir. 1976) (en banc) ............................................... 28, 30 

Nader v. EPA, 

 859 F.2d 747 (9th Cir. 1988) ................................................................... 45 

Nat'l Corn Growers Ass'n v. EPA, 

 613 F.3d 266 (D.C. Cir. 2010) ............................. 29, 36, 40, 46, 52, 53, 63 

New York v. Reilly, 

 969 F.2d 1147 (D.C. Cir. 1992) ............................................................... 29 

NRDC v. Johnson, 

 461 F.3d 164 (2d Cir. 2006) ..................................................................... 45 
vii

NRDC v. Muszynski, 

 268 F.3d 91 (2d Cir. 2001) ....................................................................... 28 

Nw. Coal. for Alternatives to Pesticides v. EPA, 

 544 F.3d 1043 (9th Cir. 2008) ........................................................... 29, 62 

Rainwater v. Alarcon, 

 268 Fed. Appx. 531 (9th Cir. 2008) ......................................................... 47 

Riverkeeper, Inc. v. EPA, 

 358 F.3d 174 (2d Cir. 2004) ............................................................... 28, 30 

Rodriguez v. City of New York, 

 72 F.3d 1051 (2d Cir. 1995) ..................................................................... 47 

Semler v. Oregon State Bd. of Dental Exam'rs, 

 294 U.S. 608 (1935) ................................................................................. 47 

Small Refiner Lead Phase-Down Task Force v. EPA, 

 705 F.2d 506 (D.C. Cir. 1983) ................................................................. 29 

Triton Energy Corp. v. Square D Co., 

 68 F.3d 1216 (9th Cir. 1995) ................................................................... 60 

Weinberger v. Hynson, Westcott & Dunning, Inc., 

 412 U.S. 609 (1973) ........................................................................... 36, 52   

RULES

Fed. R. Civ. P. 56(c)(2) ................................................................................. 35 

STATUTES

5 U.S.C. §§ 551-559...................................................................................... 27 
viii

5 U.S.C. § 706(2)(A) ..................................................................................... 28 

7 U.S.C. § 136 - 136y ..................................................................................... 4 

21 U.S.C. § 331(a) .......................................................................................... 5 

21 U.S.C. § 342(a)(2)(B) ................................................................................ 5 

21 U.S.C. § 346a ......................................................................................... 1, 5 

21 U.S.C. § 346a(a) ......................................................................................... 5 

21 U.S.C. § 346a(a)(1)-(2) .............................................................................. 5 

21 U.S.C. § 346a(b)(2)(A)(i) .......................................................................... 5 

21 U.S.C. § 346a(b)(2)(A)(ii) ..................................................................... 5, 6 

21 U.S.C. § 346a(b)(2)(C) ........................................................................ 6, 61 

21 U.S.C. § 346a(b)(2)(C)(i) ..................................................................... 6, 55 

21 U.S.C. § 346a(b)(2)(C)(i)(II) ................................................................... 63 

21 U.S.C. § 346a(b)(2)(C)(ii) ......................................................................... 6 

21 U.S.C. § 346a(b)(2)(D) .............................................................................. 6 

21 U.S.C. § 346a(d)-(g) .................................................................................. 7 

21 U.S.C. § 346a(d)(1)(A) .............................................................................. 7 
ix

21 U.S.C. § 346a(d)(2) and (3) ....................................................................... 7 

21 U.S.C. § 346a(d)(4)(A) .............................................................................. 7 

21 U.S.C. § 346a(g) ...................................................................................... 34 

21 U.S.C. § 346a(g)(2) .................................................................................. 40 

21 U.S.C. § 346a(g)(2)(A) .................................................................... 1, 8, 45 

21 U.S.C. § 346a(g)(2)(B) ........................................................................ 8, 49 

21 U.S.C. § 346a(g)(2)(C) .............................................................................. 8 

21 U.S.C. § 346a(h) ........................................................................................ 1 

21 U.S.C. § 346a(h)(1) .................................................................................... 1 

21 U.S.C. § 346a(p) .................................................................................. 9, 56 

21 U.S.C. § 346a(q) ...................................................................................... 14 

CODE OF FEDERAL REGULATIONS

40 C.F.R. § 26.1602(b)(2) ............................................................................. 12 

40 C.F.R. § 26.1603 ................................................................................ 11, 12 

40 C.F.R. § 26.1701 ...................................................................................... 11 

40 C.F.R. § 26.1704 ...................................................................................... 11 

40 C.F.R. § 158.500(d) ................................................................................. 10 

40 C.F.R. § 178.25(a)(2) ....................................................................... 1, 8, 45 

40 C.F.R. § 178.27(d) ................................................................................... 48 
x

40 C.F.R. § 178.32(b) ......................................................................... 8, 34, 35 

40 C.F.R. § 178.32(b)(1) ............................................................................... 34 

40 C.F.R. § 178.32(b)(2) ....................................................... 35, 37, 40, 47, 49 

40 C.F.R. § 178.32(b)(3) ......................................................................... 35, 37 

FEDERAL REGISTER

63 Fed. Reg. 71,542 (Dec. 28, 1998) .............................................................. 9 

71 Fed. Reg. 29,624 (May 23, 2006) ............................................................ 15 

71 Fed. Reg. 43,906 (Aug. 2, 2006).............................................................. 55 

71 Fed. Reg. 6,138 (Feb. 6, 2006) ................................................................ 10 

72 Fed. Reg. 39,318 (July 18, 2007) ............................................................. 53 

72 Fed. Reg. 68,662 (Dec. 5, 2007) .............................................................. 13 

73 Fed. Reg. 42,683 (July 23, 2008) ............................................................... 1 

74 Fed. Reg. 54,422 (Oct. 21, 2009) ............................................................. 10 

75 Fed. Reg. 70,558 (Nov. 17, 2010) ........................................................... 10 

40 C.F.R. § 178.25(a)(2) ....................................................................... 1, 8, 45 

40 C.F.R. § 178.27(d) ................................................................................... 48 
xi

40 C.F.R. § 178.32(b) ......................................................................... 8, 34, 35 

40 C.F.R. § 178.32(b)(1) ............................................................................... 34 

40 C.F.R. § 178.32(b)(2) ....................................................... 35, 37, 40, 47, 49 

40 C.F.R. § 178.32(b)(3) ......................................................................... 35, 37 

FEDERAL REGISTER

63 Fed. Reg. 71,542 (Dec. 28, 1998) .............................................................. 9 

71 Fed. Reg. 29,624 (May 23, 2006) ............................................................ 15 

71 Fed. Reg. 43,906 (Aug. 2, 2006).............................................................. 55 

71 Fed. Reg. 6,138 (Feb. 6, 2006) ................................................................ 10 

72 Fed. Reg. 39,318 (July 18, 2007) ............................................................. 53 

72 Fed. Reg. 68,662 (Dec. 5, 2007) .............................................................. 13 

73 Fed. Reg. 42,683 (July 23, 2008) ............................................................... 1 

74 Fed. Reg. 54,422 (Oct. 21, 2009) ............................................................. 10 

75 Fed. Reg. 70,558 (Nov. 17, 2010) ........................................................... 10 
1

JURISDICTIONAL STATEMENT

Petitioner Natural Resources Defense Council (“NRDC”) challenges 

Respondent United States Environmental Protection Agency’s (“EPA”) final 

order denying NRDC’s objections to, and requests for hearing on, a prior 

order denying NRDC’s petition requesting that EPA revoke all pesticide 

tolerances for residues of dichlorvos (“DDVP”) in foods pursuant to section 

408(g) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), 21 U.S.C. 

§ 346a. See Order Denying NRDC’s Objections and Requests for Hearing, 

73 Fed. Reg. 42,683 (July 23, 2008) (SPA 37).1

 This Court has subject 

matter jurisdiction over the petition for review of the Order pursuant to 21 

U.S.C. § 346a(h), but does not have jurisdiction over issues never presented 

to EPA in the petition process, or over issues presented in NRDC’s petition 

but not included in its objections. 21 U.S.C. § 346a(g)(2)(A); 40 C.F.R. 

§ 178.25(a)(2). Petitioners timely filed their petition for review. See 21 

U.S.C. § 346a(h)(1). 

STATEMENT OF ISSUES

 1. Whether EPA reasonably denied NRDC’s request for an 

evidentiary hearing on NRDC’s claims regarding the statistical power of the 

 

1

 References to “SPA __” are to the Special Appendix attached to 

Petitioner’s Brief. References to “A __” are to Petitioner’s Appendix. 

References to “SA __” are to the Supplemental Appendix filed by 

Respondent EPA.
2

DDVP human study where NRDC neither proffered evidence relevant to the 

statistical question EPA decided in its petition denial order nor specifically 

contested the actual factual determination EPA made? 

 2. Whether EPA reasonably denied NRDC’s request for an 

evidentiary hearing on the question of whether the DDVP human study’s 

informed consent process met ethical standards where NRDC presented no 

evidence that the consent process failed the applicable ethical standards? 

 3. Whether, as alleged, EPA based its denial of NRDC’s request 

for an evidentiary hearing based on the burdens of holding such a hearing? 

 4. Whether EPA’s authority under 21 U.S.C. § 346a(a)(2)(C) to 

use a children’s safety factor other than the presumptive tenfold (10X) safety 

factor depends on the completion of the endocrine screening program under 

21 U.S.C. § 346a(p)? 

 5. Whether EPA supported its decision to use a threefold (3X) 

children’s safety factor with reliable, DDVP-specific data? 

STATEMENT OF THE CASE 

I. Introduction 

While EPA was in the process of conducting a statutory review of the 

safety of the pesticide DDVP, NRDC petitioned EPA to revoke all DDVP 

tolerances, which established safe levels for DDVP residues in food. After 
3

finishing the statutory review and concluding that the mitigation steps taken 

by the pesticide registrant had reduced DDVP risks to an acceptable level, 

EPA considered NRDC’s petition to revoke the DDVP tolerances. EPA 

found that NRDC had raised several significant points meriting revisions to 

the DDVP risk assessment, but also found that the risk assessment, as 

revised, did not show DDVP to be unsafe. EPA thus denied the petition to 

revoke the DDVP tolerances. 

 NRDC filed administrative objections and requested a hearing. 

NRDC’s objections in large part ignored the reasoning EPA put forward for 

denying the petition and simply repeated claims from that petition. For 

example, NRDC’s objections failed to address the final report of an 

independent scientific review board that was absolutely central to EPA’s 

conclusions on several key issues in its petition denial.2

 Following review of 

 

2 Additionally, in multiple instances NRDC recycled criticisms of EPA’s 

DDVP risk assessment from its petition to its objections without apparently 

realizing that EPA had agreed with NRDC’s concern and revised its DDVP 

risk assessment accordingly. See, e.g., 73 Fed. Reg. at 42,698 (SPA 52) 

(based on NRDC petition EPA drops reliance on FDA Total Diet Study in 

favor of more appropriate residue data; NRDC repeats criticism of FDA 

Total Diet Study in its objections); Id. at 42,701-02 (SPA 55-56) (in 

response to NRDC petition claim that EPA should not average residential 

exposure over 120 days, EPA modifies risk assessment to examine 1-day, 

14-day, and 91-day exposures; NRDC repeats criticism of 120-day average 

in objections); Id. at 42,702-03 (56-57) (in response to NRDC petition claim 

that it was not conservative to assume that the maximum residential 

exposure is 16 hours per day, EPA revised risk assessment to assume 24 
4

the objections and hearing requests, EPA issued its 2008 order denying 

NRDC’s objections and hearing request. 

 NRDC seeks review in this Court of the 2008 order. As to the 

objection denial it challenges, NRDC relies on two arguments. The first, a 

legal argument, was never presented to EPA and is contradicted by the plain 

language of the FFDCA. The second argument has no support in the record 

and ignores EPA’s reliance on a finding by the independent science review 

board. As to the hearing denials, NRDC cannot overcome the underlying 

lack of materiality of its objections given that it merely recycled its claims 

without addressing EPA’s analyses and conclusions in the petition denial 

order. In particular, NRDC’s hearing denial challenge collapses because of 

its failure to address in any way EPA’s adoption of the independent 

scientific review board’s findings that considered and rejected NRDC’s 

various arguments. 

II. Statutory and Regulatory Background 

 EPA regulates pesticides under the FFDCA, as amended by the Food 

Quality Protection Act of 1996 (“FQPA”), and the Federal Insecticide, 

Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136 - 136y. FIFRA 

 

hours per day exposure; NRDC repeats challenge to use of 16 hours per day 

assumption in its objections). 
5

imposes a federal licensing scheme on the sale, distribution and use of 

pesticides; the FFDCA regulates pesticide residues in food. 

A. The FFDCA’s Statutory Scheme 

 The FFDCA authorizes EPA to establish by regulation “tolerances” 

setting the maximum permissible levels of pesticide residues in foods. 21 

U.S.C. § 346a. A food containing pesticide residue is deemed “unsafe” 

unless a tolerance has been set and the residue is within the limits of the 

tolerance, or an exemption from the tolerance has been set for the pesticide 

residue. Id. § 346a(a)(1)-(2). An “unsafe” food may not be moved in 

interstate commerce legally. Id. §§ 331(a), 342(a)(2)(B), 346a(a). 

 EPA may establish or leave in effect a tolerance for a pesticide only if 

EPA determines that the tolerance is “safe.” Id. § 346a(b)(2)(A)(i). The 

term “safe” is defined to mean “that there is a reasonable certainty that no 

harm will result from aggregate exposure to the pesticide chemical residue, 

including all anticipated dietary exposures and all other exposures for which 

there is reliable information.” Id. § 346a(b)(2)(A)(ii). In determining safety, 

EPA must consider relevant factors including “the validity, completeness, 

and reliability of the available data,” “the nature of any toxic effect,” “the 

aggregate exposure levels of consumers (and major identifiable subgroups of 
6

consumers),” and “the variability of the sensitivities of major identifiable 

subgroups of consumers.” Id. § 346a(b)(2)(D). 

 Tolerances must reflect an assessment of the risks posed by pesticide 

residues to infants and children (collectively, “children”) based on available 

information concerning, among other things, “the special susceptibility of 

infants and children to the pesticide chemical residues, including 

neurological differences between infants and children and adults.” Id. 

§ 346a(b)(2)(C)(i). The standard of safety for children is the same as for 

other groups: the tolerance must “ensure that there is a reasonable certainty 

that no harm will result to infants and children from aggregate exposure to 

the pesticide chemical residue.” Id. § 346a(b)(2)(C)(ii) (emphasis added); 

cf. id. § 346a(b)(2)(A)(ii). To help achieve this protection, “an additional 

tenfold margin of safety for the pesticide chemical residue and other sources 

of exposure shall be applied for infants and children to take into account 

potential pre- and post-natal toxicity and completeness of the data with 

respect to exposure and toxicity to infants and children.” Id. 

§ 346a(b)(2)(C). This margin of safety is only presumptive. The statute 

provides that “[n]otwithstanding such requirement for an additional margin 

of safety,” EPA is permitted to “use a different margin of safety for the 
7

pesticide chemical residue [but] only if, on the basis of reliable data, such 

margin will be safe for infants and children.” Id.

B. Administrative Procedures Governing Petitions to Revoke 

 FFDCA Pesticide Tolerances 

 The FFDCA specifies rulemaking procedures for the establishment, 

modification, or revocation of tolerances. Id. §§ 346a(d)-(g). The 

discussion here focuses on the law applicable to the procedure pertaining to 

the petition filed by NRDC to revoke the DDVP tolerances. 

 “Any person may file with [EPA] a petition proposing the issuance of 

a regulation . . . establishing, modifying, or revoking a tolerance for a 

pesticide chemical residue in or on a food.” Id. § 346a(d)(1)(A). If the 

filing requirements are met, EPA must publish within 30 days a notice of the 

petition’s filing. Id. § 346a(d)(2) and (3). After publication of the notice, 

EPA must, after giving “due consideration” to the petition, either (1) issue a 

final regulation establishing, modifying or revoking a tolerance; (2) issue a 

proposed regulation and then issue a final regulation after additional public 

notice and comment; or (3) issue an order denying the petition. Id. 

§ 346a(d)(4)(A). Here, EPA followed the third alternative and issued an 

order denying the petition. 

 The FFDCA creates a unique administrative procedure for interested 

parties to challenge EPA’s decision denying a tolerance petition. Within 60 
8

days after EPA issues a denial order, any person may file objections to the 

order and request a hearing on those objections. Id. § 346a(g)(2)(A). The 

objections must “specify with particularity the provision(s) of the order, 

regulation, or denial objected to, the basis for the objection(s), and the relief 

sought.” 40 C.F.R. § 178.25(a)(2); 21 U.S.C. § 346a(g)(2)(A). As to 

hearings, the FFDCA provides that EPA shall “hold a public evidentiary 

hearing if and to the extent the Administrator determines that such a public 

hearing is necessary to receive factual evidence relevant to material issues 

of fact raised by the objections.” Id. § 346a(g)(2)(B) (emphasis added). 

 EPA’s implementing regulations establish that hearings will only be 

granted when the requesting party shows that: 

(1) there is a genuine and substantial issue of fact for resolution at a 

hearing . . . ; 

(2) there is a reasonable possibility that available evidence identified 

by the requestor would, if established, resolve one or more of such 

issues in favor of the requestor . . . ; and 

(3) the resolution of the factual issues in the manner sought by the 

requestor would be adequate to justify the action requested. 

40 C.F.R. § 178.32(b). 

 After considering any objections, EPA must issue a final order 

separately stating the action taken on each objection and whether any 

hearing is appropriate. 21 U.S.C. § 346a(g)(2)(C). 
9

C. Endocrine Screening Program 

 The FQPA, and contemporaneous amendments to the Safe Drinking 

Water Act, 42 U.S.C. 300j-17, required EPA to create an estrogenic 

substances screening program “to determine whether [pesticide chemicals 

and certain other substances] may have an effect in humans that is similar to 

an effect produced by a naturally occurring estrogen, or such other endocrine 

effect as the Administrator may designate.” Id. § 346a(p)(1). 

 To aid in the design of this program, EPA created the Endocrine 

Disruptor Screening and Testing Advisory Committee, which comprised 

members representing the commercial chemical and pesticides industries, 

federal and state agencies, worker protection and labor organizations, 

environmental and public health groups, and research scientists. 63 Fed. 

Reg. 71,542, 71,544 (Dec. 28, 1998). Based on the advisory committee’s 

recommendations, EPA adopted a two-tier testing approach, with the first 

tier involving screening “to identify substances that have the potential to 

interact with the endocrine system,” and the second tier involving testing “to 

determine whether the substance causes adverse effects, identify the adverse 

effects caused by the substance, and establish a quantitative relationship 

between the dose and the adverse effect.” Id. 
10

A panel of the advisory committee, comprising distinguished 

scientists from academia, government, industry, and the environmental 

community, made specific recommendations as to appropriate studies for the 

two tiers. For Tier 1, the panel suggested a battery of short-term in vitro and 

in vivo assays. 63 Fed. Reg. at 71,550-51. As to Tier 2 testing concerned 

with potential endocrine effects on humans, the panel recommended a twogeneration reproduction study in rats -- a study required for agricultural 

pesticides since 1984. Id. at 71,555; see 40 C.F.R. §158.500(d). Pursuant to 

the suggestion of the panel, EPA has adopted modifications to this study to 

enhance its ability to detect endocrine effects. 

 EPA has issued orders requiring that 67 pesticide chemicals undergo 

the full battery of testing specified under the Agency’s endocrine disruptor 

screening program. 74 Fed. Reg. 54,422 (Oct. 21, 2009). A draft list of 

second group of chemicals was recently published. 75 Fed. Reg. 70,558 

(Nov. 17, 2010). 

D. Human Research Rule 

 EPA decisions regarding the ethics of human studies are governed by 

the Protection for Subjects in Human Research final rule (“Human Research 

Rule”). 71 Fed. Reg. 6,138 (Feb. 6, 2006). The framework of the Human 

Research Rule rests on the basic principle that EPA will not, in its actions, 
11

rely on data derived from unethical research. The rule divides studies 

involving intentional dosing of human subjects into two groups: those 

initiated after April 7, 2006 (the effective date of the rule) and those initiated 

before April 7, 2006. This case involves a study initiated before April 7, 

2006. 

As to pre-April 7, 2006 studies, the Human Research Rule forbids 

EPA from relying on such data “if there is clear and convincing evidence 

that the conduct of the research was fundamentally unethical (e.g., the 

research was intended to seriously harm participants or failed to obtain 

informed consent) or was significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted.” 40 C.F.R. § 

26.1704. Further, reflecting the concern that scientifically invalid data are 

“always unethical,” 71 Fed. Reg. at 6160, the rule limits the human research 

that can be relied upon by EPA to “scientifically valid and relevant data.” 

40 C.F.R. § 26.1701. 

 To aid EPA in making scientific and ethical determinations under the 

Human Research Rule, the rule established an independent Human Studies 

Review Board to review both proposals for new research and reports of 

completed human research on which EPA proposes to rely. Id. § 26.1603. 

If EPA decides to rely on the results from pre-April 7, 2006 research 
12

conducted to identify or measure a toxic effect, EPA must submit the results 

of its assessment to the Review Board for evaluation of the ethical and 

scientific merit of the research. Id. § 26.1602(b)(2). 

 The rule directs that the Human Studies Review Board shall be 

composed of non-EPA employees “who have expertise in fields appropriate 

for the scientific and ethical review of human research, including research 

ethics, biostatistics, and human toxicology.” Id. § 26.1603(a). The members 

of the Human Studies Review Board at the time it reviewed the DDVP 

human study were 16 distinguished experts in the fields of bioethics, 

biostatistics, human health risk assessment and human toxicology, primarily 

from academia. 73 Fed. Reg. at 42,713 (SPA 67). 

III. Procedural History of the NRDC Petition 

 Dichlorvos, or DDVP, is an insecticide registered for use in 

commercial structures, including agricultural and food-handling facilities, 

and private homes. 72 Fed. Reg. at 68,669 (A 218). DDVP is a member of 

the organophosphate family of pesticides, and like other organophosphates, 

DDVP’s principal hazard to human health is its effect on the nervous 

system.3

 Id. 

 

3 NRDC’s brief also makes various allegations concerning DDVP’s 

carcinogenic potential. Pet. Br. at 9-10. In its petition to revoke DDVP 

tolerances, NRDC challenged EPA’s assessment of DDVP’s cancer risk. 
13

 To assess the risk of DDVP, EPA has focused on DDVP’s ability to 

inhibit the cholinesterase enzyme in red blood cells. 73 Fed. Reg. at 42,691 

(SPA 45). Inhibition of cholinesterase is a disruption of the normal process 

by which the nervous system chemically communicates with muscles and 

glands. Id. at 42,688 (SPA 42). EPA does not consider cholinesterase 

inhibition in red blood cells to be an adverse health effect but rather an 

indicator of a chemical’s “potential for adverse effects on the nervous 

system.” 73 Fed. Reg. at 42,689 (SPA 43). 

 EPA has established different safe doses for DDVP depending on 

whether exposure is short- or long-term and whether exposure is by the oral, 

dermal, or inhalation route. In calculating these safe doses, EPA has used 

differing safety factors based on whether the safe dose calculation relies on 

animal or human toxicity data. For safe doses based on animal data, EPA 

has applied a 100X safety factor – 10X for extrapolation from animals to 

humans, and 10X for variability in human sensitivity. For safe doses based 

on human data, EPA has applied a 30X safety factor – 10X for variability in 

human sensitivity, and 3X under the children’s safety factor provision. EPA 

 

(A59-60). EPA dismissed this claim, noting that it had relied on the advice 

of numerous external peer reviews that concluded that the tumors seen in 

DDVP animal studies had little or no relevance to humans. 72 Fed. Reg. 

68,662, 68,673 (Dec. 5, 2007) (SPA 211, 222). NRDC did not file an 

objection challenging this finding. 
14

has not applied a children’s safety factor when relying on animal data for 

DDVP. Id. at 42,691 (SPA 45). 

A. FIFRA Reregistration/FFDCA Tolerance Reassessment for 

DDVP 

 EPA was required by the FIFRA amendments of 1988 and the Food 

Quality Protection Amendments of 1996 to reevaluate the safety of DDVP. 

See 21 U.S.C. § 346a(q). This reevaluation of DDVP safety was completed 

in July 2006. 73 Fed. Reg. at 42,691 (SPA 45). The reevaluation process 

indicated that risks from exposure to DDVP in food and water were low but 

that various residential uses of DDVP posed risks of concern.4

 SA000055. 

Prior to completion of the reevaluation, the DDVP manufacturer proposed 

amendments to its FIFRA registration pertaining to the residential uses to 

address these risks. 73 Fed. Reg. at 42,691 (SPA 45). 

 An important component of the reevaluation process included review 

of several DDVP toxicity studies involving human subjects under EPA’s 

newly promulgated Human Research Rule. EPA’s initial conclusion was 

that one of the studies, a study involving repeated dosing over several days 

 

4 Risks from DDVP residues in food are particularly low. 72 Fed. Reg. at 

68,686 (A 235). DDVP residues in drinking water pose higher risks, but 

EPA found that dietary exposure from food and water was ‘insignificant 

compared to exposures from [residential] pest strips.” 73 Fed. Reg. at 

42,699 (SPA 53). The primary sources of DDVP are other registered 

pesticides that degrade to DDVP in the environment. 72 Fed. Reg. at 68,679 

(A 228).
15

conducted in 1997 by A.J. Gledhill (hereinafter referred to as the “Gledhill 

study”), met the ethical and scientific standards in the Human Research Rule 

but that the others did not. 73 Fed. Reg. at 42,692 (SPA 46). EPA sought 

the advice of the Human Studies Review Board on all of the studies. 

 The Human Studies Review Board held a public meeting on April 4-6, 

2006, to review the DDVP studies and human studies for several other 

pesticides. NRDC filed written comments with the Review Board 

concerning DDVP, A 277, and also presented oral testimony at the public 

meeting. SA000003. NRDC’s comments and oral remarks focused on 

whether human studies had sufficient statistical power “to detect an effect 

when it may occur.” SPA 289. On May 23, 2006, the Human Studies 

Review Board published a notice in the Federal Register seeking public 

comment on a draft report. 71 Fed. Reg. 29,624 (May 23, 2006). NRDC 

filed no comments. 

 On June 26, 2006, the Human Studies Review Board issued its finding 

that reliance on the Gledhill human study was appropriate given that the 

study had scientific value and there was no clear and convincing evidence 

that the study was fundamentally unethical. 73 Fed. Reg. at 42,692 (SPA 

46). The Review Board concluded that the other DDVP human studies 
16

should not be used in the DDVP risk assessment. SA000063. These 

findings were unchanged from its draft report. 

 EPA agreed with the findings of the Human Studies Review Board 

and relied on the Review Board’s reasoning in using the Gledhill study in its 

reevaluation of DDVP safety. 72 Fed. Reg. at 68,675 (A 224). 

B. NRDC’s Petition to Revoke Tolerances 

 On June 2, 2006, prior to the completion of the DDVP 

reregistration/tolerance reassessment process, NRDC filed a petition 

requesting, among other things, that by August 3, 2006, EPA conclude the 

FIFRA reregistration process with a finding that DDVP is not eligible for 

reregistration and revoke all DDVP tolerances. The petition raised myriad 

claims, including allegations that: (1) EPA had unlawfully reduced the 

children’s safety factor to 3X because EPA had provided “no explanation” 

of why a 3X factor is safe for children, EPA lacked a developmental 

neurotoxicity study, and a study from the scientific literature showed the 

young are more sensitive to DDVP, A 56-57; (2) EPA cannot conclude the 

DDVP tolerances are safe because the DDVP docket does not “indicate that 

the Agency has conducted [the statutorily-required endocrine] screening or 

[other] in-depth studies of DDVP’s potential for endocrine disruption,” A 

70; and (3) EPA cannot rely on any of the DDVP toxicity studies using 
17

human subjects because these studies do not meet the standards in EPA’s 

Human Research Rule, A 68. With regard to the human studies, NRDC 

argued in particular that the Gledhill study was scientifically and ethically 

flawed because its low number of subjects made it “statistically 

meaningless,” and the study’s informed consent process was marred by the 

description of DDVP as a “drug.” Id. To support these claims NRDC cited 

several specific statements in the draft report of the Human Studies Review 

Board on the Gledhill study. NRDC failed to note, however, that the Board 

had concluded that the Gledhill study was consistent with the standards in 

EPA’s Human Research Rule. Id. 

 Following EPA’s release of its reregistration/tolerance reassessment 

decision, NRDC filed comments on that decision on August 28, 2006. 73 

Fed. Reg. at 42,692 (SPA 46); SA000132. Many of those comments 

expanded on arguments made in its June 2, 2006 petition. 

C. EPA’s Response to the Petition to Revoke Tolerances 

 In response to NRDC’s petition (including NRDC’s August 2006 

comments), EPA addressed all of NRDC’s contentions in great detail and 

made substantial changes to its DDVP risk assessment. Nonetheless, EPA 

denied the petition because, even under the revised risk assessment, the 
18

DDVP tolerances met the FFDCA safety standard. 72 Fed. Reg. at 

68,691(A 240). 

 With regard to the three claims noted above, EPA rejected each of 

NRDC’s arguments. First, as to the children’s safety factor, EPA provided 

an extensive explanation for the safety factors it used for the various 

different DDVP risk assessments (e.g., acute, short-term, chronic exposures 

by oral, dermal, and inhalation routes). EPA specifically addressed NRDC’s 

concerns regarding the absence of a developmental neurotoxicity study and 

the literature study showing sensitivity of the young. EPA explained that 

two developmental neurotoxicity studies had been received and incorporated 

into the risk assessment and that these studies resolved the neurotoxicity 

issues raised by the literature study. 72 Fed. Reg. at 68,694-95 (A 243-44). 

Further, EPA provided a detailed explanation for its children’s safety factor 

decisions for DDVP, including discussion of the most relevant toxicity 

studies, adult-young sensitivity evaluations, and the exposure data and 

assessments. In particular, as to the 3X children’s safety factor retained in 

assessments relying on the Gledhill study, EPA explained that its choice of a 

3X safety factor relied heavily on the Human Studies Review Board’s 

scientific evaluation of the likelihood of whether adverse effects would 
19

occur at doses lower than the dose level at which effects were seen in the 

Gledhill study. Id. at 68,695 (A 244). 

 Second, EPA disagreed with NRDC’s claim that EPA had not 

adequately considered DDVP’s potential to disrupt endocrine systems in 

making its safety determination. EPA described the extensive mammalian 

toxicity data (from dog, rat, and mouse studies) that it reviewed in 

evaluating possible endocrine effects. 72 Fed. Reg. at 68,676-77 (A 225-

226). That data included a study similar to the one chosen under the 

endocrine screening program for use in Tier 2 testing with regard to 

mammalian effects. Id. at 68,676 (A 225). EPA noted that although 

potential endocrine effects were found, these effects occurred at 

substantially higher exposure levels than the adverse effect (cholinesterase 

inhibition) upon which the risk assessment was based. EPA concluded that 

it had adequate data to make a safety finding as to DDVP’s potential 

endocrine-related effects because: “(1) data bearing on potential endocrine 

effects from a two-generation reproduction study as well as other chronic 

data in which effects on reproductive organs were examined; (2) EPA well 

understands DDVP’s most sensitive mechanism of toxicity (cholinesterase 

inhibition); and (3) the potential endocrine-related effects seen for DDVP 

appeared in the presence of significant cholinesterase inhibition and at levels 
20

nearly two orders of magnitude above the most sensitive cholinesterase 

effects.” Id. at 68,677 (A 225). 

 Third, EPA disagreed with NRDC’s claim that the Gledhill study was 

not consistent with the Human Research Rule. EPA noted that the Human 

Studies Review Board had specifically considered NRDC’s statistical 

arguments and criticisms of the consent process and had rejected them. Id.

at 68,675 (A 224). Regarding statistics, EPA noted the Review Board’s 

careful evaluation of the strengths and weaknesses of the Gledhill study. 

Important to the Board was the repeated dose approach which allowed 

examination of the sustained nature of red blood cell cholinesterase 

inhibition; robust analysis of RBC cholinesterase inhibition both in terms of 

identifying pre-treatment levels and consistency of response within and 

between subjects; and the observation of a low, but statistically significant 

RBC cholinesterase inhibition response. Id. EPA adopted the reasoning of 

the Human Studies Review Board. Id. Directly responding to NRDC’s 

claims that there were too few subjects in the study and that the study lacked 

“statistical power,” EPA added that: 

Although as a general matter more subjects would provide 

greater “statistical power,” in this case the use of 6 to 9 subjects 

with the appropriate statistical methodology is acceptable to 

EPA because a positive response was seen. Indeed, all of the 6 

dosed subjects exhibited statistically significant (with respect to 

their pre-dose levels) RBC cholinesterase depression on one or 
21

more days . . . . The statistics of the study clearly show the 

ability to demonstrate a statistically significant response. 

Id. Also, in addressing NRDC’s concern regarding extrapolating a safe dose 

from the subjects in the Gledhill study, EPA noted that “an intra-species 

safety factor of 10X was applied to the study results to address variability in 

human sensitivity.” 72 Fed. Reg. at 68,675 (A 224). 

 Regarding informed consent, the Human Studies Review Board 

concluded that there was no clear and convincing evidence that certain 

references to DDVP as a “drug” in the consent form showed “that informed 

consent was not obtained.” Id. Critical to the Board was that “the consent 

materials clearly advised subjects that this was a study involving consuming 

an insecticide.” Id. Again, EPA accepted the Review Board’s analysis. 

D. NRDC’s Objections 

 Following EPA’s denial of NRDC’s petition, NRDC filed objections 

to that ruling and requested a hearing on those objections. Four of those 

objections are relevant to this proceeding. First, NRDC argued that EPA 

erred in reducing the children’s safety factor from 10X to 3X because EPA 

had based this decision on a “generic assertion” rather than “on any data 

specific to DDVP.” A 252. Second, NRDC objected that EPA erred in 

reducing the children’s safety factor because “EPA has never conducted 
22

screening or in-depth studies of DDVP’s potential for endocrine disruption.” 

Id. 

 Third, NRDC claimed that the Gledhill study did not comply with 

EPA’s Human Research Rule because of statistical inadequacies. NRDC’s 

objection on this point mostly consists of categorical statements unsupported 

by evidence. For example, NRDC asserts that “[w]e are aware of no 

statistical test which would support the establishment of a reliable NOAEL 

[no observed adverse effects level] or dose response curve derived from just 

6 test subjects from any toxicity study in any test species,” the Gledhill study 

“lack[s] . . . statistical power,” and “the results [of the Gledhill study] are of 

limited value because the test subjects were all adult males.” A 260-61. 

Moreover, all of this language was drawn verbatim from the comments 

NRDC filed in August 2006 on EPA’s statutory review of the safety of 

DDVP. Compare A 260-61and SA000146. 

 Finally, NRDC claimed that the Gledhill study did not comply with 

EPA’s Human Research Rule because of the “misleading characterizations 

to [sic] DDVP as a ‘drug’.” A 259. 
23

E. EPA’s Denial of Objections and Hearing Requests 

 EPA denied each of NRDC’s objections and hearing requests. With 

regard to the matters raised in this petition for review, EPA took the 

following actions: 

 1. Denial of objection – Reduction of children’s safety factor based 

on non-specific DDVP data. EPA denied NRDC’s objection that EPA’s 

children’s safety factor determination was based on a “generic assertion” 

rather than “on any data specific to DDVP,” because that objection is flatly 

contradicted by the record. 73 Fed. Reg. at 42,696 (SPA 50). As EPA 

explained, and the record clearly shows, EPA’s determination was based on 

the DDVP animal and human testing data and on the Human Studies Review 

Board’s analysis of the human testing data. EPA concluded: “EPA chose a 

safety factor of 3X for DDVP based on its conclusion that not only was 10X 

overprotective but that 3X would be protective given the results seen in the 

relevant DDVP study.” Id. 

 2. Denial of objection – Reduction of children’s safety factor 

unlawful because of lack of endocrine screening data or other endocrine 

data. EPA denied this objection because it was a new claim not presented in 

the original petition for revocation. Although NRDC made a similar claim 

about the lack of endocrine data in its administrative petition, NRDC 
24

specifically tied that alleged deficiency to EPA’s safety finding, not to 

EPA’s decision on the children’s safety factor. Id. Nonetheless, EPA 

analyzed the objection as if it had been properly made and denied it because, 

first, it was premised on the incorrect legal argument that completion of the 

endocrine screening program was a mandatory prerequisite to removal or 

reduction of the children’s safety factor, Id. at 42,696-97 (SPA 50-51), and 

second, NRDC’s claim that EPA did not have data on endocrine effects was 

flatly wrong, Id. at 42,697-98 (SPA 51-52); moreover, NRDC’s sole 

response to EPA’s detailing of that information was merely to speculate that 

some other test might have showed something different. Id. at 42,698 (SPA 

52). 

 3. Denial of hearing request – statistical deficiency rendering 

Gledhill study scientifically invalid. EPA read NRDC’s objection on this 

issue as raising three separate claims: (1) the Gledhill study lacks “statistical 

power to detect effects caused by the test substance above background 

variations,” A 260; (2) the Gledhill study had insufficient subjects to 

“support the establishment of a reliable NOAEL or dose response curve,” 

Id.; and (3) the Gledhill study is of limited value because it only used adult 

males, A 261. 
25

 EPA denied a hearing on the “statistical power” issue because this 

issue is not material. As EPA explained, “statistical power measures the 

probability that a toxicological study will find a treatment-related adverse 

health outcome when there is a treatment-related adverse effect to be found.” 

73 Fed. Reg. at 42,705 (SPA 59). Statistical power is a critical measurement 

in evaluating whether a toxicity study is showing a false negative (i.e., 

falsely indicating that the test substance does not cause an adverse effect). 

But with the Gledhill study, the issue of false negatives was not a concern. 

The Gledhill study investigated DDVP’s impact on cholinesterase inhibition 

in red blood cells, and the study confirmed that cholinesterase was

inhibited.5

 EPA thus rejected all of the scientific articles NRDC submitted 

on statistical power because they were directed at the false negative 

question, despite the fact that the question of false negatives was not 

presented by the Gledhill study, as NRDC’s articles acknowledged. See, 

e.g., A 264. 

 EPA denied a hearing on NRDC’s claim that the Gledhill study had 

insufficient test subjects because (1) NRDC submitted no evidence in 

 

5

 The title of the study is “Dichlorvos: A Single Blind, Placebo Controlled, 

Randomized Study to Investigate the Effects of Multiple Oral Dosing on 

Erythrocyte Cholinesterase Inhibition in Healthy Male Volunteers.” EPAHQ-OPP-2002-0302-0211; See also A 264(“the only biological end point 

measured in the study was cholinesterase inhibition, and this was 

significantly inhibited.”)
26

support of this claim, and thus the claim was nothing more than a “mere 

allegation” for which NRDC was not entitled to a hearing under EPA’s 

regulation; and (2) NRDC’s objection failed to confront the reasoning EPA 

gave in its petition denial as to why the Gledhill study had sufficient subjects 

for the purposes for which it served in EPA’s risk assessment. EPA 

explained that this affected the materiality of the objection because “[e]ven 

if NRDC could demonstrate in a hearing that generally more test subjects are 

needed to derive a . . . [safe dose], that evidence would not address the 

specific factors in the Gledhill study that EPA and the [Human Studies 

Review Board] found convincing on this question.” 73 Fed. Reg. at 42,706 

(SPA 60). 

 Finally, EPA denied a hearing on NRDC’s objection to the Gledhill 

study’s use of only adult males for basically the same reason. First, NRDC 

proffered no evidence on the representativeness of adult males to the general 

population. Second, NRDC did not object to the basis given in EPA’s 

petition denial for why the Gledhill study provided valuable information 

despite the use of adult males only, namely, the fact that animal testing with 

DDVP showed no differences in sensitivities in regard to cholinesterase 

inhibition between males and females or adults and juveniles. Thus, this 
27

objection, like the last one, was nothing more than a “mere allegation and 

not a material challenge to the petition denial.” Id. at 42,707 (SPA 61). 

 4. Denial of hearing request – informed consent issue. EPA denied a 

hearing on NRDC’s objection concerning consent in the Gledhill study for 

two reasons. First, EPA concluded that there were no disputed facts at issue. 

NRDC raised no dispute as to what information was presented to the study 

participants and proffered no other evidence on consent. EPA concluded 

that “the only question is the legal/policy one of whether use of the Gledhill 

study consent form is ‘clear and convincing evidence’ that the Gledhill study 

was ‘fundamentally unethical’ and thus not in compliance with EPA 

regulations.” Id. at 42,708 (SPA 62). EPA regulations do not permit 

hearings on questions of law or policy. Second, once again, NRDC’s 

objection was not material because NRDC had not confronted EPA’s 

reasoning in the denial order – that the Human Studies Review Board had 

concluded that consent was informed based on information showing that the 

subjects had been told the test substance was an insecticide. Id. 

STANDARD OF REVIEW

 Judicial review under the FFDCA is governed by the standards set 

forth in the Administrative Procedure Act (“APA”), 5 U.S.C. §§ 551-559, 

701-706, which establishes a highly deferential standard of review for 
28

agency action. Such action is valid unless it is “arbitrary, capricious, an 

abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 

706(2)(A). 

 This Court has held that “review under this provision is narrow, 

limited to examining the administrative record to determine whether the 

[agency] decision was based on a consideration of the relevant factors and 

whether there has been a clear error of judgment.” Riverkeeper, Inc. v. EPA, 

358 F.3d 174, 184 (2d Cir. 2004) (citations and internal quotes omitted); see 

also NRDC v. Muszynski, 268 F.3d 91, 97 (2d Cir. 2001) (same). The Court 

“may not substitute its judgment for that of the agency[.]” Id. at 97 (citation 

and internal quotation omitted). Rather, the Court should affirm EPA’s 

decision unless EPA has: 

relied on factors which Congress has not intended it to consider, 

entirely failed to consider an important aspect of the problem, 

offered an explanation for its decision that runs counter to the 

evidence before the agency, or is so implausible that it could 

not be ascribed to a difference in view or the product of agency 

expertise. 

Id. (citation and internal quotations omitted). In short, this standard of 

review presumes the validity of agency action, Ethyl Corp. v. EPA, 541 F.2d 

1, 34 (D.C. Cir. 1976) (en banc), and if the agency’s reasons and policy 

choices conform to “certain minimal standards of rationality,” the action is 
29

reasonable and must be upheld. Small Refiner Lead Phase-Down Task 

Force v. EPA, 705 F.2d 506, 521 (D.C. Cir. 1983). 

 This highly deferential standard of review applies to review of EPA’s 

decisions establishing tolerances under the FFDCA. Nw. Coal. for 

Alternatives to Pesticides v. EPA, 544 F.3d 1043, 1047-48 (9th Cir. 2008); 

Cmty. Nutrition Inst. v. Young, 773 F.2d 1356, 1363 (D.C. Cir. 1985). The 

same highly deferential standard applies to review of EPA decisions 

determining whether an issue is material and supports a request for an 

evidentiary hearing under the FFDCA and EPA regulations. Nat’l Corn 

Growers Ass’n v. EPA, 613 F.3d 266, 271-72 (D.C. Cir. 2010) (Although 

EPA regulations establish a “summary-judgment type” standard for 

determining whether to hold a hearing, “our review of the EPA’s exercise of 

discretion in determining whether an issue is material differs from our 

review of a summary judgment rendered by a district court, which we review

de novo.”) 

 When an agency’s decision rests on an evaluation of complex 

scientific data within the agency’s technical expertise and judgment, courts 

are “extremely deferential.” New York v. Reilly, 969 F.2d 1147, 1152 (D.C. 

Cir. 1992); see also Browning-Ferris Indus. of S. Jersey, Inc., v. Muszynski, 

899 F.2d 151, 160 (2d Cir. 1990). The Court “must look at the decision not 
30

as the chemist, biologist, or statistician that [it is] qualified neither by 

training nor experience to be, but as a reviewing court exercising [its] 

narrowly defined duty of holding agencies to certain minimal standards of 

rationality.” Ethyl Corp., 541 F.2d at 36; see also Riverkeeper, 358 F.3d at 

184 (this Court “lack[s] the EPA’s expertise when it comes to scientific or 

technical matters”). 

SUMMARY OF ARGUMENT

NRDC filed objections to, and sought a hearing on, EPA’s denial of 

its petition to revoke DDVP tolerances. The FFDCA requires that such 

objections be made “with particularity” to the challenged order. Further, 

EPA regulations provide that an evidentiary hearing will be conducted only 

if EPA determines that the requesting party has submitted material that 

presents a genuine and substantial issue of fact and there is a reasonable 

possibility that the evidence, if established, would resolve one or more issues 

in favor of the requesting party in a manner that would be adequate to justify 

the action requested. EPA reasonably exercised its technical expertise and 

discretion in determining that NRDC’s request for a hearing failed to satisfy 

statutory and regulatory requirements with respect to each of NRDC’s 

claims. 
31

 First, NRDC’s claim that the Gledhill study lacked statistical power 

necessary to avoid a false finding that DDVP is harmless is irrelevant 

because the Gledhill study found the effect it was investigating. NRDC also 

argues that the study had too few subjects to produce scientifically reliable 

data for establishing a safe dose for DDVP, but NRDC failed to 

acknowledge, must less address and submit evidence contesting, EPA’s 

finding in its petition denial order that the results of the Gledhill study, 

despite the relatively low number of subjects, were “sufficiently robust” for 

assessing DDVP risks. EPA’s finding rejecting NRDC’s challenge to the 

scientific validity of the Gledhill study was based on a thorough analysis of 

the study by the Human Studies Review Board and was exhaustively 

explained in its petition denial order. Because NRDC did not, “with 

particularity,” address and submit evidence contesting this central 

conclusion in EPA’s order, EPA reasonably – and necessarily – found that 

NRDC failed to demonstrate the existence of a genuine, dispositive issue of 

material fact requiring an evidentiary hearing. 

 Second, NRDC’s objection to the informed consent determination for 

the Gledhill study also did not show a disputed factual issue meriting a 

hearing. Although an EPA staff member, the Human Studies Review Board 

and EPA each reviewed the informed consent form used in the Gledhill 
32

study and found significant deficiencies in the consent form, each also 

concluded that, on whole, the study met applicable ethical standards for 

informed consent. NRDC disputes none of the underlying facts bearing on 

informed consent, but nonetheless argues it is entitled to an evidentiary 

hearing on this issue. However, NRDC created no fact issue on this point 

because it framed its challenge as a purely legal one and offered no factual 

evidence for development at a hearing, such as testimony from an expert 

who had reviewed the informed consent materials, to support its argument. 

Further, similar to its statistical objection, NRDC failed to object “with 

particularity” to EPA’s conclusion on informed consent in the petition denial 

order and thus NRDC’s objection (and hearing request) is irrelevant and 

immaterial. 

 Third, there is no support in the record to support NRDC’s assertion 

that EPA based its denial of NRDC’s hearing request on the grounds that an 

evidentiary hearing would be burdensome. EPA’s denial was based entirely 

on its determination that NRDC failed to satisfy applicable statutory and 

regulatory requirements. 

 EPA also acted reasonably and in accordance with law in reaching its 

finding that a 3X children’s safety factor was supported by the scientific 
33

data, and that the FFDCA’s presumptive 10X factor was unnecessary to 

protect children. 

 First, EPA selected a 3X safety factor based on available data that 

EPA determined to be reliable. NRDC claims that EPA could not depart 

from the presumptive 10X safety factor without first having the results of an 

endocrine screening program required by statute. NRDC forfeited any 

argument that screening program results are scientifically necessary because 

NRDC failed to raise this argument in its petition to revoke the tolerance, 

and instead asserted it for the first time in its objection. In any event, 

NRDC’s argument that the FFDCA requires that EPA obtain screening 

program results before departing from the 10X safety standard is contrary to 

the plain language of the statute. 

 Second, EPA concluded that a 3X factor was safe based on its 

comprehensive evaluation of DDVP-specific data, and not, as NRDC 

alleges, some “generic assertion” about safety. NRDC’s argument that EPA 

chose 3X simply because it is half of 10X is based on a misreading of the 

record. NRDC’s argument that EPA must calculate a “mathematically 

precise” safety factor is wrong; the FFDCA requires EPA to select a safety 

factor that it determines is safe, just as it did here. Finally, NRDC’s claim 

that the human study data and animal study data cannot be considered in 
34

combination to assess risks is asserted for the first time in this Court and is 

not supported by any evidence in the record. 

 EPA’s scientific judgment is entitled to deference. There is no 

evidence that EPA abused its discretion or acted in violation of law, and 

EPA’s decision must therefore be upheld. 

ARGUMENT 

I. NRDC Did Not Satisfy the Standard for Obtaining an Evidentiary 

 Hearing Under the FFDCA. 

 NRDC was entitled to a hearing on its objections to EPA’s 2008 order 

only “if and to the extent [EPA] determines that such a public hearing is 

necessary to receive factual evidence relevant to material issues of fact 

raised by the objections.” 21 U.S.C. § 346a(g). EPA has implemented this 

statutory provision by promulgating regulations articulating specific 

requirements that must be satisfied before a request for hearing will be 

granted. 40 C.F.R. § 178.32(b). 

First, the hearing request must involve “a genuine and substantial 

issue of fact . . . .” Id. § 178.32(b)(1). Evidentiary hearings “will not be 

granted on issues of policy or law.” Id. Second, the hearing request and 

submitted supporting material must show that “[t]here is a reasonable 

possibility that available evidence identified by the requestor would, if 

established, resolve one or more of such issues in favor of the requestor, 
35

taking into account uncontested claims or facts to the contrary.” Id. 

§ 178.32(b)(2) (emphasis added). “An evidentiary hearing will not be 

granted on the basis of mere allegations, denials, or general descriptions of 

positions and contentions, nor if the Administrator concludes that the data 

and information submitted, even if accurate, would be insufficient to justify 

the factual determination urged.” Id. (emphasis added). Finally, the hearing 

request must demonstrate that “[r]esolution of the factual issue(s) in the 

manner sought by the person requesting the hearing would be adequate to 

justify the action requested.” Id. § 178.32(b)(3). Hearings will not be 

granted on issues that will not affect the outcome. Id. 

 While the process for deciding whether to conduct an evidentiary 

hearing is often described as “summary judgment-like,” the threshold 

showing required to trigger a hearing is higher under the regulations than 

under rules applicable to summary judgment. A civil litigant can defeat 

summary judgment and obtain a hearing by demonstrating a genuine issue of 

material fact, Fed. R. Civ. P. 56(c)(2), while a party objecting to a tolerance 

must not only establish the existence of a genuine and substantial fact issue, 

but also each of the other requirements of 40 C.F.R. § 178.32(b). This 

higher threshold is permissible because Congress has “great leeway” in 

setting standards regarding the regulation of chemicals, whereas there are 
36

“sharper limitations on the use of summary judgment.” See Weinberger v. 

Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 622 (1973) (finding Food 

and Drug Administration “hearing regulations unexceptionable on any 

statutory or constitutional ground”). “Properly viewed, the objection stage is 

an opportunity for internal agency review, an opportunity for an interested 

party to challenge -- and for the agency to correct -- a matter of fact, law, or 

policy that appeared for the first time in the Final Regulation, so-called.” 

Nat’l Corn Growers, 613 F.3d at 273. 

 NRDC claims that EPA arbitrarily and capriciously determined that 

NRDC’s hearing request failed to meet all of the requirements of 40 C.F.R. 

§ 178.32(b) with respect to two issues: (1) whether the Gledhill study 

lacked adequate statistical power; and (2) whether the consent given by 

study participants met applicable standards for informed consent. NRDC’s 

claims must be rejected for the reasons discussed below. 

 A. NRDC’s claims regarding the statistical power of the DDVP 

 human study did not raise issues of fact material to EPA’s 

 tolerance decision. 

 NRDC claims that, because the Gledhill study involved six test 

subjects, the study lacks “statistical power” to detect a health risk from 

DDVP or determine an exposure level that is a safe dose for humans. Pet. 

Br. at 21. EPA specifically examined each of these claims, determined that 
37

the evidence submitted by NRDC was not material to EPA’s denial of 

NRDC’s petition to revoke the DDVP tolerance, and denied NRDC’s 

hearing request. 73 Fed. Reg. at 42,704-06 (SPA 58-60). EPA’s decision 

was not arbitrary or capricious. 

 Statistical power is a concept used to measure the probability that a 

given sample size in a study will be able to find an effect if such an effect is 

present. Analysis of a study’s statistical power is important to avoid false 

negatives (i.e., concluding that a pesticide is harmless when in fact it is not). 

As EPA explained, however, the issue of a study’s statistical power is 

irrelevant if the study has found the effect it is looking for. Id. at 42,705-06 

(SPA 59-60). DDVP is a cholinesterase-inhibiting pesticide. As NRDC 

acknowledges, the Gledhill study was designed to test for cholinesterase 

inhibition, and it found such inhibition. It is undisputed that the Gledhill 

study did not produce a false negative, therefore any evidence about the 

statistical power of the Gledhill study is not material to EPA’s decision to 

rely on the study to detect a risk of cholinesterase inhibition, and could not 

have changed that decision. Accordingly, NRDC’s hearing request on this 

subject failed to satisfy the requirements of 21 U.S.C. § 346a(g)(2)(B) and 

40 C.F.R. § 178.32(b)(2) and (3). 
38

 Whether the Gledhill study had an adequate number of subjects for 

EPA to rely on its result in establishing a safe dose for DDVP is potentially a 

relevant objection to EPA’s use of the study. However, NRDC’s request for 

hearing on this issue also failed to satisfy requirements for obtaining a 

hearing because NRDC failed to submit any evidence in support of its 

objection and, contrary to the requirements of EPA’s regulations, NRDC’s 

objection failed to address EPA’s findings in the petition denial. 

 NRDC asserted in its petition to revoke the tolerances that the 

Gledhill study had too few subjects. EPA rejected this claim in its petition 

denial, relying on the Human Studies Review Board’s conclusion that the 

Gledhill study “was sufficiently robust for developing a [safe dose] for 

estimating dermal, incidental oral, and inhalation risk from exposure to 

DDVP in a single chemical assessment.” 72 Fed. Reg. at 68,675 (A 224). 

EPA and the Board cited many factors in support of their conclusions as to 

the robustness of the Gledhill study data, including: “the repeated dose 

approach which allowed examination of the sustained nature of RBC 

cholinesterase inhibition; robust analysis of RBC cholinesterase inhibition 

both in terms of identifying pre-treatment levels and consistency of response 

within and between subjects; and the observation of a low, but statistically 

significant RBC cholinesterase inhibition response.” Id. EPA also noted 
39

that “the group means of RBC cholinesterase activity in treated subjects are 

statistically below the group means of the placebo controls on days 7, 11, 14, 

16 and 18 by [the statistical measure of ]repeated measures analysis of 

variance. The statistics of the study clearly show the ability to demonstrate a 

statistically significant response.” Id. Finally, EPA noted that in addition to 

the 3X children’s safety factor, it was applying a 10X safety factor to 

address “variability in human sensitivity.” 72 Fed. Reg. at 68,675 (A 224). 

Thus, in computing a safe dose for DDVP based on the Gledhill data, EPA 

used an overall safety factor of 30X. 

 In response to EPA’s detailed statistical analysis of the results of the 

Gledhill study, NRDC’s objection offered nothing more than the statement 

that: “We are aware of no statistical test which would support the 

establishment of a reliable NOAEL or dose response curve derived from just 

6 subjects.”6

 A 260. This statement is taken verbatim from NRDC 

 

6 NRDC did contest EPA’s statement in the petition denial that the number of 

subjects was not meaningfully different than the subjects in a chronic 

toxicity study in dogs (four per dose for each sex), a required test for 

pesticides. NRDC claimed, without providing any support, that the dog 

study was also statistically meaningless and rarely relied upon by EPA. A 

260. In response, EPA noted that (1) the requirement for a chronic dog 

study was a long-standing one; (2) EPA had only recently repromulgated by 

rule the requirement for a chronic dog study; (2) the U.S. Food and Drug 

Administration and governmental agencies in other major developed 

countries all recommend the same number of subjects in the chronic dog 

study; and (3) a review of EPA actions showed frequent reliance on the 
40

comments filed with EPA in August 2006 – 15 months prior to EPA’s denial 

of the petition to revoke DDVP tolerances. SA000132. 

EPA properly concluded that a hearing was not appropriate on such an 

objection. First, the objection was nothing more than a “mere allegation” or 

“denial” of EPA’s position; under EPA’s hearing regulations, hearing 

requests based on mere allegations or denials must be denied. 40 C.F.R. § 

178.32(b)(2). Second, by failing to contest EPA’s specific conclusions in its 

petition denial order but simply recycling comments made earlier to EPA, 

NRDC’s objection and the supporting materials failed to satisfy the 

materiality requirement of the statute and the rule. As the D.C. Circuit 

recently held: “[T]he petitioners, by simply re-submitting their Comments, 

without addressing the responses the EPA had made to them in the Final 

Regulation, ‘failed to lodge a relevant objection.’ . . . By statute, an 

Objection and Hearing Request must be directed ‘with particularity [to] the 

provisions of the [final rule] deemed objectionable.’ 21 U.S.C. § 346a(g)(2); 

see also 40 C.F.R. § 178.25(a)(2).” Nat’l Corn Growers, 613 F.3d at 273. 

 None of the “evidence” submitted by NRDC with its hearing request 

addresses EPA’s (and the Human Studies Review Board’s) detailed findings 

 

chronic dog study, including in the DDVP risk assessment. 73 Fed. Reg. at 

42,706 (SPA 60). Hearings are not warranted on mere allegations and 

NRDC has not argued, in this Court, that its unsupported claims regarding 

the chronic dog study justified a hearing. 
41

with regard to the statistical merit of using the Gledhill study for calculating 

a safe dose. NRDC’s evidence contains nothing more than generalized 

conclusions about “statistical power,” which, as explained above, is 

irrelevant to the Gledhill study. None of the evidence supports a conclusion 

that the Gledhill study had too few subjects to support EPA’s decision 

establishing a safe dose. Moreover, none of the evidence even addresses the 

other factors that EPA relied on to support its decision. Each of NRDC’s 

submissions is analyzed below: 

 1. Sass & Needleman, Industry Testing of Toxic Pesticides on Human 

Subjects Concluded “No Effect,” Despite the Evidence. A 264. The authors 

of this letter to the editor dispute -- as did EPA -- the DDVP registrant’s 

claim that the Gledhill study showed no effect on cholinesterase inhibition. 

The authors broadly criticize the use of just “a handful of healthy adult 

subjects” in studies, claiming that “[s]uch studies often lack enough subjects 

to provide adequate statistical power to detect an effect if it is present.” Id. 

The authors make no attempt to explain how this general criticism applies to 

the Gledhill study, which did detect the presence of the effect being studied. 

 2. Sass & Needleman, Human Testing: Sass and Needleman 

Respond to Industry (A 265-66). This short follow-up to the authors’ earlier 

letter does nothing other than repeat the generalized criticism that small 
42

sample sizes result in low statistical power, and provide a computation of the 

statistical power of such studies. Implicitly acknowledging that the 

possibility of a false negative did not occur in the Gledhill study, this letter 

approvingly cites EPA’s conclusion that the Gledhill study did show a 

statistically- and biologically-significant effect on cholinesterase. Id. at 265. 

 3. Lockwood, Human Testing of Pesticides: Ethical and Scientific 

Considerations. A 267-75. This article provides a broad critique of human 

studies. It contains a short discussion of statistical power in relation to the 

Gledhill study and five other studies. However, this discussion states 

nothing more than: “A power analysis to define the proper size of study 

group(s) is an essential part of design. [] If too few [subjects] are enrolled, 

the investigator risks erroneous acceptance of the null hypothesis [i.e. a false 

negative]. Underpowered studies are inconclusive . . . . All of these studies 

were underpowered.” A 271 (emphasis added). The author did not 

comment about the fact that the risk of a false negative did not materialize in 

the Gledhill study. Moreover, the author says nothing about whether the 

statistically-significant results found in the Gledhill study are appropriate for 

use in calculating a safe dose. 

 4. Sass, PowerPoint Presentation to the Human Studies Review 

Board. A 277-98. This presentation contains four PowerPoint slides that 
43

address DDVP, A 286-89, and several slides generally discussing statistical 

power. The latter slides state that statistical power is a critical element of 

study design because “[a] study with inadequate power to find an effect is by 

definition unethical.” These slides also contain a hypothetical computation 

to show how many subjects would be needed for a study to have adequate 

power to detect an effect that occurred in one out of one thousand children. 

None of this speaks to the Gledhill study given that that study found the 

effect it was looking for. As to DDVP, there is one slide primarily 

addressing cancer risk, two slides supporting EPA’s conclusion that a 

significant cholinesterase effect was seen in the Gledhill study, and one slide 

offering a few general science/policy criticisms of human studies. A 289. 

The presentation contains no analysis of whether the statistically-significant 

results seen in the Gledhill study are appropriate for calculating a safe dose. 

 5. Lockwood, The Ethical Bar Drops to Unacceptable. A 276. This 

one-page article for a legal publication briefly summarizes the author’s 

longer article and critiques EPA’s proposed Human Research Rule. 

Lockwood repeats his earlier conclusion that the six studies he reviewed 

were “statistically invalid,” but presents no analysis or explanation. In a 

parenthetical remark, Lockwood reminds the reader that “Vioxx was tested 

on thousands and used by millions” before it was withdrawn because of 
44

drug-related complications.” Id. The author makes no effort to relate this 

statement to the Gledhill study, and says nothing about the validity of a 

statistical analysis of a study that did identify effects without being “tested 

on thousands.” 

 As NRDC nears the end of its argument about the reliability of the 

Gledhill study it shifts ground, claiming that EPA “missed the point,” and 

failed to recognize that “an underpowered study is unreliable for two 

reasons: (1) it could identify a harmful effect at the wrong exposure level; 

and (2) it could fail to detect other harmful effects entirely.” Pet. Br. at 26 

(emphasis in original). This argument is unavailing for several reasons. 

 First, as explained above, EPA did identify the first argument, which 

is just another way of restating NRDC’s claim that EPA could not rely on 

the Gledhill study to establish a safe dose. EPA denied a hearing on this 

claim because (1) it was based on nothing more than a mere allegation 

without supporting evidence and (2) NRDC failed to object to the detailed 

statistical analysis EPA presented as to why the Gledhill study results were 

“sufficiently robust” to use in setting a safe dose. See Section I.A, supra. 

 Second, EPA could not have identified the “fail to identify other 

effects” argument, because no mention of it appears in the part of NRDC’s 

objections cited in its brief (i.e., A 260-61), or elsewhere. NRDC’s omission 
45

violates the requirement that objections “[s]pecify with particularity . . . the 

basis for the objections.” 40 C.F.R. § 178.25(a)(2); 21 U.S.C. 

§ 346a(g)(2)(A). This requirement makes clear that EPA need not analyze 

an objector’s submissions and respond to objections that, in theory, could 

have been made. Because this claim could have been -- but was not -- raised 

in NRDC’s objection as required by section 346(g), NRDC may not raise the 

claim in this Court. NRDC v. Johnson, 461 F.3d 164, 173 (2d Cir. 2006) 

("[I]f it is or was possible to obtain review under the administrative review 

procedures of Section 346a(g), then Section 346a(h) limits judicial review to 

the courts of appeals and forecloses such review prior to the exhaustion of 

administrative remedies.); cf. Nader v. EPA, 859 F.2d 747, 753-54 (9th Cir. 

1988) (interpreting parallel pre-FQPA provision of the FFDCA as requiring 

exhaustion of internal procedures before challenging denial of petition for 

rulemaking in court of appeals). 

Finally, even if the claim were properly before this Court, it is 

disingenuous for NRDC to claim that this is a serious objection to the 

Gledhill study. As NRDC’s filings and cited articles admit, DDVP is a 

cholinesterase-inhibiting pesticide and the Gledhill study was designed to 

investigate cholinesterase inhibition in red blood cells. The Gledhill study 

did not detect harmful effects other than red blood cholinesterase inhibition 
46

because it only examined cholinesterase inhibition, not because of some 

statistical deficiency in the study. 

 Based on its expertise, EPA determined that NRDC’s hearing request 

and supporting evidence were too generic and conclusory to be material to, 

raise a genuine fact issue about, or be determinative of, the issue of whether 

EPA reasonably relied on the Gledhill study as one factor in establishing a 

tolerance for DDVP. The administrative record does not support a 

conclusion that EPA abused its discretion, and the Court should not 

substitute its judgment for the Agency’s on such highly technical matters. 

See Nat’l Corn Growers, 613 F.3d at 273. 

B. NRDC presented no evidence that raised material issues of 

 fact on which NRDC could reasonably prevail on the 

 question of whether the Gledhill study’s informed 

 consent process met ethical standards. 

 NRDC argues that EPA arbitrarily denied NRDC’s request for a 

hearing to determine whether the Gledhill study complied with ethical 

standards applicable to the informed consent process. Pet. Br. at 27. No 

hearing was required because NRDC failed to present any evidence that 

created a disputed issue of fact that had a reasonable possibility of being 

resolved in NRDC’s favor. 

 The question of whether the informed consent process complied with 

ethical standards could involve fact issues about what occurred during that 
47

process. Cases relied on by NRDC articulate this principle. E.g., Rainwater 

v. Alarcon, 268 Fed. Appx. 531, 534 (9th Cir. 2008). Here, however, 

NRDC’s objections failed to raise such issues. The evidence concerning the 

consent process is not in dispute. The consent form used in the Gledhill 

study is included in the study report, and NRDC proferred no evidence 

suggesting that there were other disputed facts relevant to the process of 

obtaining consent from participants in the study. 

 Instead, in its objection and hearing request, NRDC framed the 

adequacy of the Gledhill consent form as a legal issue, arguing, for example, 

that the form “would have violated FIFRA Section 12(a)(2)(P).” A 261. 

EPA properly declined NRDC’s request for a hearing on such issues, 73 

Fed. Reg. at 42,703 (SPA 57), because “evidentiary hearings may not be 

obtained to resolve legal issues.” 40 C.F.R. § 178.32(b)(2). 

Given that NRDC is not disputing the facts concerning the consent 

process, NRDC, to justify a hearing, would have to, at a minimum, present 

testimony of a qualified expert that the informed consent process in the 

Gledhill study was unethical and failed to obtain the informed consent of the 

subjects. See Rodriguez v. City of New York, 72 F.3d 1051, 1063 (2d Cir. 

1995) (conflicting expert testimony regarding what is the customary and 

acceptable medical standard creates an issue of fact); cf. Semler v. Oregon 
48

State Bd. of Dental Exam’rs, 294 U.S. 608, 612 (1935) (“What is generally 

called the ‘ethics’ of the profession is but the consensus of expert opinion as 

to the necessity of such standards.”). NRDC, however, proffered no such 

testimony. 

In fact, NRDC’s hearing request referenced no evidence to suggest 

that it could, at an evidentiary hearing, present clear and convincing 

evidence that the consent form failed to comply with ethical standards 

applicable to informed consent. NRDC’s claim that it did submit factual 

evidence is based on two documents that concluded that the consent form 

met ethical standards (an internal memorandum authored by EPA employee 

John Carley, A 3-5, and a draft report by the Human Studies Review Board 

on DDVP, A 26-42), and an article by author who states that he did not 

review the consent form (Alan Lockwood article, A 267-75).7

 NRDC, 

however, cannot create a fact issue by its attorney’s arguments that Mr. 

Carley, the Human Studies Review Board, and EPA reached the wrong 

 

7 Only two of these three documents, however, are even mentioned in its 

objections, and nowhere does NRDC explain what evidence they contain, 

contrary to the requirements of 40 C.F.R. § 178.27(d). 
49

conclusion. As the statute makes clear, hearings are for the purpose of 

“receiv[ing] factual evidence.” 21 U.S.C. § 346a(g)(2)(B).8

Mr. Carley’s memorandum does note the undisputed fact that the 

consent form refers to the test substance as “the drug.” However, NRDC’s 

brief fails to note that Mr. Carley’s memorandum concluded that there was 

no clear and convincing evidence that the Gledhill study did not obtain 

informed consent. See A 5. Accordingly, the Carley memorandum is not 

evidence that creates a reasonable possibility that the informed consent issue 

would be resolved in NRDC’s favor, and it does not support a hearing 

request. See 40 C.F.R. § 178.32(b)(2). 

 NRDC’s reliance on misleadingly juxtaposed sentence fragments 

from the draft report of the Human Studies Review Board, Pet. Br. at 28, 

also fails to provide evidence that would support a finding in NRDC’s favor. 

While the draft report contains statements critical of aspects of the disclosure 

form, “[t]he Board determined that there was not clear and convincing 

evidence that references to the test material as a drug . . . that appear in the 

materials to obtain informed consent should be considered significantly 

 

8 NRDC also implies that a hearing is needed so that a “neutral arbiter” can 

resolve these “facts.” Pet. Br. at 30. But more is needed to justify a hearing 

than a desire for a neutral arbiter. To the extent NRDC seeks a neutral 

arbiter, it could have appealed EPA’s objection denial to this Court for 

determination of whether EPA reasonably relied on an independent scientific 

body’s judgment on informed consent. But NRDC has not done so.
50

deficient relative to the ethical standards prevailing when the study was 

conducted.” A 41. The draft also notes that “other wording in the consent 

materials clearly advised subjects that this was a study involving consuming 

an insecticide.” Id. (emphasis added). Moreover, like the Carley 

memorandum, the Human Studies Review Board concluded that there was 

no clear and convincing evidence that the Gledhill study did not obtain 

informed consent. 

 Finally, the Lockwood article, A 267-75, does not satisfy the need for 

an expert opinion on consent or otherwise create a genuine and substantial 

issue of fact, as required by 40 C.F.R. § 178.32(b)(2), because Lockwood 

never reviewed the consent form for the Gledhill study. Lockwood 

summarized his review of six studies in a table. A 269. The Gledhill study 

appears in row three of that table. In the column titled “Written Informed 

Consent Available,” Lockwood entered “No, but protocol states ‘volunteers 

completed a consent form.’” Id. Thus, when Lockwood gave as an example 

of unacceptable deficiencies in consent documents the “failure to identify 

the test compound as a pesticide,” he could not have been referring to his 

review of the Gledhill consent documents. Even if he were referring to that 

study, testimony of an expert who has not examined the consent form cannot 

create a factual issue. See, e.g., Triton Energy Corp. v. Square D Co., 68 
51

F.3d 1216 (9th Cir. 1995) (testimony of expert who had not examined 

allegedly defective product could not establish fact issue).

 C. EPA did not deny any hearing request based on 

 consideration of the burden of holding a hearing. 

 NRDC claims that EPA denied NRDC’s hearing requests because 

EPA thought it would be a burden to hold such a hearing. Pet. Br. at 32. 

The administrative record contradicts NRDC’s claim. 

 In a closing section of its denial order, EPA summarized its grounds 

for denying NRDC’s hearing requests: “EPA’s close examination of each of 

the 19 sub-issues involved in these two hearing requests demonstrates that 

none of the issues satisfies the standard for granting a hearing in 40 C.F.R. 

§ 178.32. Most fail for multiple reasons.” 73 Fed. Reg. at 42,709 (SPA 63). 

EPA then summarized the issues that did not present an issue of genuinely 

disputed fact, were not material, or were unsupported by evidence which, if 

established, would resolve the issue in NRDC’s favor. Id. at 42,709-10 

(SPA 63-64). 

EPA next commented that NRDC’s failure to offer relevant evidence 

in support of its contentions through the several stages of the tolerance 

setting had defeated the goal of making the regulatory process no more 

resource intensive than necessary. “Presumably, Congress created a multistage administrative process for resolution of tolerance petitions to give EPA 
52

the opportunity in the first stage of the proceeding to resolve factual issues, 

where possible, through a notice-and-comment process, prior to requiring 

EPA to hold a full evidentiary hearing -- which can involve a substantial 

investment of resources by all parties taking part.” Id. at 42,710 (SPA 64). 

Accord Nat’l Corn Growers, 613 F.3d at 272-73 (rulemaking stage of the 

process would be “redundant and superfluous” if a party can withhold 

evidence from EPA until the objection stage).9

 EPA, however, was clear 

that this consideration raised questions of concern, but was not a ground for 

its order in this case: “In these circumstances [i.e., NRDC’s failure to 

submit evidence at earlier stages of this proceeding], EPA questions whether 

granting a hearing would have been appropriate even if NRDC had, at this 

last stage of the administrative process, suddenly produced factual evidence 

in support of its claims.” 73 Fed. Reg. at 42,710 (SPA 64) (emphasis added) 

 EPA did not rely on an improper factor to deny NRDC’s hearing 

requests. 

 

9

 Effective use of agency resources is an appropriate consideration in 

establishing procedures limiting the availability of evidentiary hearings. 

Hynson, 412 U.S. at 621 (“If FDA were required automatically to hold a 

hearing for each product whose efficacy was questioned . . ., even though 

many hearings would be an exercise in futility, we have no doubt that it 

could not fulfill its statutory mandate to remove from the market all those 

drugs which do not meet the effectiveness requirements of the Act.”).
53

II. EPA’s Decision to Apply a 3X Children’s Safety Factor was 

 Neither Contrary to Law Nor Arbitrary or Capricious. 

A. EPA properly denied NRDC’s objection to EPA’s 

 children’s safety factor decision based on the absence of 

 data from endocrine screening program because it was not 

 raised in NRDC’s petition. 

 EPA has interpreted 21 U.S.C. 346a(g)(2) as requiring that tolerance 

petitioners exhaust their claims through the administrative petition process 

and bars claims filed for the first time in objections. “The FFDCA's 

tolerance revocation procedures are not some sort of ‘game,’ whereby a 

party may petition to revoke a tolerance on one ground, and then, after the 

petition is denied, file objections to the denial based on an entirely new 

ground not relied upon by EPA in denying the petition.” 72 Fed. Reg. 

39,318, 39,324 (July 18, 2007); see Nat’l Corn Growers, 613 F.3d at 272-73 

(“The EPA’s refusal to consider at the objections stage evidence and 

arguments that could have been but were not submitted during the comment 

period is also of a piece with the general rule of forfeiture we apply when 

reviewing agency decisions, viz., that the court will not consider an 

argument the agency was not given a fair opportunity to consider during the 

rulemaking.”) (citations omitted). In its petition, NRDC claimed that EPA 

lacked sufficient data on endocrine effects to determine the safety of DDVP. 

EPA responded by explaining in detail the data it did have on endocrine 
54

effects and why that data permitted it to make a safety finding. In its 

objections, NRDC raised a new argument, namely, that the absence of data 

from the endocrine screening program established by 21 U.S.C. § 346a(p) 

invalidated EPA’s decision on the children’s safety factor. Because this 

argument was not presented in NRDC’s petition, EPA properly denied it as 

waived. 

B. EPA’s authority to establish an appropriate children’s 

 safety factor does not depend on the completion of the 

 endocrine screening program. 

 Even assuming NRDC’s challenge to EPA’s children’s safety factor 

decision based on the absence of data from the endocrine screening program 

is properly before this Court, it is without merit. NRDC contends that the 

FFDCA requires EPA to apply the presumptive tenfold (10X) children’s 

safety factor to a pesticide unless the endocrine screening program has been 

completed for that pesticide. Pet. Br. at 34-37. NRDC does not contest 

EPA’s factual finding regarding the extensive data it has on endocrine 

effects.10 The plain language of the statute does not support NRDC’s 

reading. 

 

10 In its objections, NRDC argues that EPA’s existing data are not adequate 

under the endocrine screening program, but does not substantively contest 

EPA’s scientific conclusion that these studies provide valuable information 

on potential endocrine effects. A 252-53. 
55

 The children’s safety factor provision, 21 U.S.C. § 346a(a)(2)(C), 

requires that in establishing tolerances “an additional tenfold margin of 

safety . . . shall be applied for infant(s) and children to take into account 

pre- and post-natal toxicity and completeness of the data with respect to 

exposure and toxicity to infants and children,” but also provides that 

“[n]othwithstanding such requirement for an additional margin of safety, the 

Administrator may use a different margin of safety for the pesticide 

chemical residue only if, on the basis of reliable data, such margin will be 

safe for infants and children.” Section 346a(a)(2)(C) leaves it to EPA’s 

discretion to determine what constitutes “completeness of the data” and 

“reliable data,” and requires only that EPA’s assessment of risks be based on 

“available information.” 21 U.S.C. § 346a(a)(2)(C)(i). The children’s safety 

factor provision contains no requirement that data from the endocrine 

screening program mandated by 21 U.S.C. § 346a(p) be available before 

EPA can use its discretion to depart from the presumptive margin of safety. 

EPA has consistently interpreted the statute in this manner. 71 Fed. Reg. 

43,906, 43,920 (Aug. 2, 2006) (“EPA's contemporaneous and consistent 

approach to the endocrine screening program has been to treat that 

information-gathering exercise as not imposing some type of statutorily-
56

prescribed, automatic injunction barring removal of the children's safety 

factor until completion of information-gathering under the program.”). 

 Similarly, nothing in the provision creating the endocrine screening 

program, 21 U.S.C. § 346a(p), refers to – let alone limits – EPA’s discretion 

to adjust the children’s safety factor before the screening program has been 

completed. The provision mandates that EPA implement the screening 

program, but requires only that EPA take appropriate action after receiving 

results from the screening program: “In the case of any substance that is 

found, as a result of testing and evaluation under this section, to have an 

endocrine effect on humans, the Administrator shall, as appropriate, take 

action under such statutory authority as is available to the Administrator . . . 

as is necessary to ensure the protection of public health.” 21 U.S.C. 

§ 346a(p)(6). 

 The unambiguous requirements of the FFDCA cannot be amended by 

NRDC’s interpretation of “congressional purpose and common sense.” Pet. 

Br. at 35. Congress imposed requirements to ensure that EPA’s regulation 

of pesticides accounted for the completeness and reliability of available data; 

waiting for the results of the endocrine screening program was not one of 

those requirements. In rejecting NRDC’s petition to revoke the tolerances, 

EPA explained why, in the absence of results from the screening program, 
57

available data on DDVP’s endocrine effects allowed EPA to evaluate 

DDVP’s safety. A 225-26. NRDC did not object to that finding, and its 

legal argument is contrary to the statute. 

C. EPA supported its children’s safety factor decision with 

 reliable, DDVP-specific data. 

 EPA properly denied NRDC’s objection that EPA’s choice of a 3X 

children’s safety factor “is a generic assertion not based on any data specific 

to DDVP.” A 252. NRDC’s claim is flatly contradicted by the record. 

 In its denials of NRDC’s petition and objections, EPA provided a 

comprehensive explanation of its reasoning on its children’s safety factor 

decision stressing at each point the relevant DDVP data. In that explanation, 

EPA addressed each of the key factors mentioned in the children’s safety 

factor provision – the completeness of the toxicity and exposure databases 

and potential pre- and post-natal toxicity – as well as all of the concerns 

raised by NRDC. With regard to the toxicity database, EPA focused on the 

completeness issues raised by NRDC – relating to developmental 

neurotoxicity and endocrine effects – explaining in detail what data was 

available on those effects and why that data could be reliably used in 

choosing a safe dose for infants and children. 72 Fed. Reg. at 68,676-77 and 

68,984 (A 225-226 and 243). EPA also discussed the results of each study 

involving the testing of young animals and explained why it believed all 
58

concerns regarding potential increased sensitivity in the young from pre- and 

post-natal toxicity were addressed by its risk assessment. Id. at 68,694 (A 

243). In large part, this conclusion was based on data showing similar 

sensitivity in adults and the young to DDVP’s cholinesterase effects, the 

effect that occurs at the lowest dose.11 Id. 

 Based on this comprehensive evaluation, EPA determined that, for 

DDVP risks where the calculation of a safe dose was based on animal data, 

the additional factor for the protection of infants and children could be 

removed in its entirety. Id. However, EPA concluded that, for DDVP risks 

where calculation of a safe dose was based on the human data from the 

Gledhill study, a children’s safety factor of 3X should be retained. This 

additional safety factor for infants and children was not retained because the 

Gledhill study involved only adults. As EPA has noted, cholinesterase data 

on DDVP in animals shows no differences in the responses of adults and the 

young. Rather, an additional safety factor was considered necessary because 

of a weakness in the Gledhill study – namely, the study only identified a 

dose level at which cholinesterase inhibition would occur and not a dose at 

 

11 In addition, EPA explained, as to each of its exposure assessments (food, 

water, and residential), why underlying data and EPA’s conservative 

assumptions assured that the assessment would not understate exposure. To 

the extent NRDC questioned the completeness of EPA’s exposure 

information, EPA responded in detail. 72 Fed. Reg. at 68,984-85 (A 243-

45).
59

which cholinesterase would not be inhibited. Id. at 68,695 (A 244). 

Accordingly, EPA evaluated whether the uncertainty raised by this weakness 

in the Gledhill study warranted retention of the 10X children’s safety factor 

or a different factor. 

In conducting this evaluation, EPA, as is its practice, examined 

whether a full 10X factor was needed or whether a 3X factor (a value EPA 

considers to be half of 10X)12 would be sufficient, rather than attempting to 

derive a mathematically precise value of the lowest possible safety factor 

needed to assess the risks of children. EPA concluded, after a close 

statistical examination of the level of the effects seen in the Gledhill study, 

that the data in the study showed that a 10X factor would be overprotective 

and that a 3X factor would sufficiently cabin the uncertainty surrounding 

 

12 EPA has explained in detail its scientific basis for why it considers half of 

a 10X safety factor to be 3X. 72 Fed. Reg. at 68,695 (A 244). More simply, 

EPA generally applies safety factors in increments of an order of magnitude 

or logarithmically when data are not available to quantitatively estimate a 

reduced safety factor. Thus, EPA generally does not use safety factors of 

1X, 2X, 3X, 4X, etc., but rather factors of 1X, 10X, 100X, 1000X, etc. 

Because EPA uses logarithmic (order of magnitude) steps in choosing safety 

factors, if EPA decides to reduce an individual safety factor by half, it does 

so logarithmically. Accordingly, half of the logarithmic value of 101

 would 

be 100.5 or approximately 3. Put another way, given that EPA combines 

safety factors by multiplying them and not adding them (e.g., combining two 

safety factors of 10X yields a value of 100X not 20X), in reducing 

individual safety factors by half it is appropriate to take the square root of 

the factor not divide by two (e.g., thus half of a 10X factor is approximately 

3X not 5X). 
60

what dose would produce no measurable effect on cholinesterase inhibition 

(i.e., 3X would be more than sufficient to protect children). EPA’s scientific 

conclusion on this point was confirmed by the Human Studies Review Board 

which concluded that “because the decreased activity in RBC [red blood 

cell] cholinesterase activity observed in this study was at or near the limit of 

what could be distinguished from baseline values, it was unlikely that a 

lower dose would produce a measurable effect in RBC cholinesterase 

activity.” 72 Fed. Reg. at 68,695 (A 244). EPA’s resolution of this complex 

scientific issue is entitled to the highest deference. See, e.g., BrowningFerris Indus., 899 F.2d at 160. 

NRDC argues that EPA’s decision was facially deficient in three 

respects, none of which is supported the FFDCA or the record in this case. 

First, NRDC claims that “EPA applied a threefold safety factor for 

dichlorvos simply because it considered that level to be about half as 

protective as a factor of ten.” Pet. Br. at 37. This is simply wrong. EPA did 

not choose a 3X factor for DDVP because 3X is half of 10X but because it 

determined that the relevant DDVP data showed that a 3X factor would be 

safe. NRDC has confused the rationale EPA has used to choose what safety 

factor below 10X it will generally consider in determining whether the value 
61

of 10X can safely be reduced, with EPA’s justification for determining that a 

3X safety factor protects the safety of children with respect to DDVP. 

Moreover, NRDC is also wrong to the extent it is claiming that EPA 

was arbitrary because, as EPA admitted, it did not attempt “to 

mathematically derive a precise replacement safety factor.” Pet. Br. at 37. 

NRDC misreads the FFDCA. The statute does not require a mathematically 

precise replacement safety factor; it requires that if EPA chooses a different 

factor that different factor must be “safe.” 21 U.S.C. § 346a(a)(2)(C). EPA 

selected a safety factor it determined to be safe and explained the data that 

supported that finding. That was all that was required.13

Second, NRDC challenges EPA’s choice of a 3X safety factor 

claiming that “EPA’s exact reasoning on this point” was found deficient by 

 

13 EPA’s remarks about mathematical precision have been taken out of 

context by NRDC. EPA was simply responding to NRDC’s claim that EPA 

had to justify why it chose 3X and rather than 4X or some other number. As 

EPA explained: 

EPA disagrees with NRDC, however, to the extent it is 

suggesting that as part of this reasoned explanation for its 

selection of a children’s safety factor, EPA must show why it 

did not choose some other mathematical value. Rather, the 

statute imposes upon EPA, if it decides to vary from the 

presumptive 10X children’s safety factor, the burden to show 

that any “different” safety factor is safe. Once EPA has made 

that showing, its obligation to offer a reasoned explanation is 

complete. 

73 Fed. Reg. at 42,696 (SPA 50).
62

the Ninth Circuit in Northwest Coalition for Alternatives to Pesticides, 544 

F.3d at 1052, a case involving three different pesticides. Pet. Br. at 39. As 

NRDC acknowledges, however, the Ninth Circuit held that “EPA must 

provide a pesticide-specific explanation for why the particular margin of 

safety applied by the agency is safe.” Id. at 38. In other words, each case 

must be decided on its own facts. EPA’s reasoning on DDVP is in no way 

similar to its children safety factor determinations that were held to be 

arbitrary in Northwest Coalition. In that case, EPA offered basically onesentence explanations for its children’s safety factor decisions and failed to 

“explain the connection between the toxicological data and the 3X margin of 

safety selected . . . .” 544 F.3d at 1052. Here, EPA has provided an 

exhaustive rationale for its decision, and NRDC has done nothing other than 

make conclusory assertions about the lack of rationality in EPA’s decision. 

Indeed, in its objections and in its opening brief, NRDC does not even 

acknowledge, must less confront, EPA’s analysis of results of the Gledhill 

study – an analysis that was both confirmed by the Human Studies Review 

Board and central to EPA’s choice of a 3X safety factor. 

 Finally, contradicting its prior “generic assertion” arguments, NRDC 

admits that EPA relied upon DDVP data in its children’s safety factor 

determination, but claims that the data do not support EPA’s decision. Pet. 
63

Br. at 38-39. NRDC’s argument here is that it was improper to consider (1) 

the Gledhill study in the children’s safety factor determination because the 

test subjects in that study were adults; and (2) the animal data showing no 

difference in adult-young sensitivity to DDVP’s cholinesterase effects – the 

very data that shows why the Gledhill study is appropriate for the entire 

population – because the Northwest Coalition for Alternatives to Pesticides

case held relative sensitivity data cannot be used to justify a 3X safety 

factor. For multiple reasons, this argument must be rejected. 

 First, this claim was never exhausted before Agency, and thus this 

Court has no jurisdiction to consider it. See Nat’l Corn Growers, 613 F.3d 

at 272-73. NRDC argued the exact opposite position to EPA in its petition 

and objections – that EPA’s children’s safety determination was unlawful 

because it relied on “generic assertions” and not “on any data specific to 

DDVP.” A 252. Second, the second prong of the argument is demonstrably 

false. The Northwest Coalition court held only that it was arbitrary for EPA 

not to explain how sensitivity information supported its decision, not that 

such information is irrelevant. NRDC’s reading of the case would contradict 

the plain statutory language requiring EPA to assess risk to children based 

on “information concerning the special susceptibility of infants and children 

to the pesticide chemical residues . . . .” 21 U.S.C. 346a(b)(2)(C)(i)(II). 
64

Third, EPA has in this proceeding addressed the question of the 

appropriateness of relying on the Gledhill study in assessing the DDVP risk. 

EPA specifically rejected NRDC’s argument that the Gledhill study’s use of 

adult subjects only made it “invalid for use by EPA to set exposure standards 

for a diverse population.” A 260. EPA made this determination relying on 

the animal cholinesterase data showing no increased sensitivity to the young 

with regard to cholinesterase effects. 73 Fed. Reg. at 42,707 (SPA 61); 72 

Fed. Reg. at 68,694 (A 243). NRDC has not challenged that scientific 

determination before this Court and that unchallenged determination is 

conclusive on this issue. Finally, to the extent that the Court believes it is 

appropriate to reach the merits of NRDC’s claim on this point, EPA’s 

explanation for why animal cholinesterase data show that the Gledhill data is 

relevant to infants and children is challenged only by NRDC’s conclusory 

assertion that this approach is irrational. NRDC has offered no scientific 

evidence or argument on this point. In these circumstances, the Court must 

defer to EPA’s scientific judgment. 

EPA’s decision to apply a 3X children’s safety factor comported with 

the FFDCA and was amply supported by evidence in the record. 

CONCLUSION 

 For the foregoing reasons, the petition for review should be denied. 
65

 Respectfully submitted, 

 IGNACIA S. MORENO 

 Assistant Attorney General 

 

 _s/ Kent E. Hanson_________ 

 KENT E. HANSON 

 Environmental Defense Section 

 Environment & Natural Resources 

 Division 

 P.O. Box 23986 

 Washington, D.C. 20530 

 (202) 514-2327 

Of Counsel: 

JONATHAN J. FLEUCHAUS 

Environmental Protection Agency 

Office of General Counsel 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 
66

CERTIFICATE OF COMPLIANCE 

 This brief complies with the type-volume limitation of Fed. R. App. P. 

32(a)(7)(B) because it contains 13,166 words excluding the parts of the brief 

exempted by Fed. R. App. P. 32(a)(7)(B)(iii). 

 This brief complies with the typeface requirements of Fed. R. App. P. 

32(a)(5) and type style requirements of Fed. R. App. P. 32(a)(6) because this 

brief has been prepared in a proportionally spaced typeface using Microsoft 

Office Word in 14 point font and Times New Roman type style. 

 s/ Kent E. Hanson 

CERTIFICATE OF SERVICE 

 I hereby certify that a copy of the foregoing was served by first-class 

mail, postage pre-paid and by e-mail, on November 18, 2010, upon: 

Aaron S. Colangelo 

Natural Resources Defense Council 

1200 New York Avenue NW, Suite 400 

Washington, DC 20005 

acolangelo@nrdc.org

 s/ Kent E. Hanson